LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY

K073552 · Laborie Medical Technologies, Corp. · FEN · Mar 5, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073552
• Device Name: LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
• Applicant: Laborie Medical Technologies, Corp.
• Product Code: FEN · Gastroenterology, Urology
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2

Intended Use

Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence. All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.

Device Story

System combines traditional urodynamic measurement (uroflowmetry, cystometry, micturition, EMG, urethral pressure profiles) with Tetra accessory for non-invasive bladder activity assessment. Tetra uses near-infrared spectroscopy (NIRS) via 785nm, 808nm, and 830nm pulsed laser (4 µsec) to monitor bladder activity. System inputs include pressure, flow, and NIRS signals; outputs are diagnostic data for lower urinary tract symptoms. Operated by clinicians in hospitals or offices. Data aids diagnosis of urinary incontinence. Safety features include electrical, laser, and electromagnetic compatibility testing.

Clinical Evidence

Bench and clinical studies confirmed efficacy. Additional safety testing included electrical safety, laser safety, and electromagnetic compatibility testing.

Technological Characteristics

Class I Equipment, Type BF Applied Parts. IPX0. Continuous operation. Uroflow rate 0-50 ml/s; pressure -40 to 350 cm H2O; EMG -225 to 225 µV (2-800 Hz). Tetra accessory: Class I laser, wavelengths 785/808/830 nm, pulsed 4 µsec, energy up to 350 mJ. Data conversion 10-1000 Hz (up to 5000 Hz optional).

Indications for Use

Indicated for patients with lower urinary tract symptoms, specifically urinary incontinence, requiring urodynamic testing. For use under direction of licensed physician or healthcare professional in office or hospital settings.

Regulatory Classification

Identification

A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Laborie Urodynamic Analyzer (K931574)

Submission Summary (Full Text)

{0}------------------------------------------------

K073552

# Laborie Medical Technologies Urodynamic System with Tetra Accessory 510(k) Summary (per 21 CFR 807.92)

#### I. Applicant

Laborie Medical Technologies, Inc. 6415 Northwest Drive, Unit 10 Mississauga Ontario Canada L4V 1X1 MAR - 5 2008

Contact Person: Barbara Mornet, Regulatory Affairs Deputy Tel: [phone] Fax: [phone] Email: [e-mail]

December 14, 2007 Date Prepared:

#### II. Device Name

| Proprietary Name: | Laborie Urodynamic System with Tetra Accessory |
|-----------------------|--------------------------------------------------------------------|
| Common/ Usual Name: | Urodynamics Measurement System |
| Classification Name: | Device, cystometric, hydraulic, cystometer<br>electrical recording |
| Regulation Number: | 876.1620, 876.1800 |
| Product Codes: | FEN, EXQ |
| Classification: | 2 |
| Classification Panel: | Gastroenterology/Urology |

#### III. Predicate Device

The Laborie Urodynamic System with Tetra accessory is substantially equivalent to the Laborie Urodynamic Analyzer with 510(k) 931574 and all subsequent models that are now 510(k) exempt.

#### IV. Intended Use of the Device

Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.

## Indications for Use

All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.

{1}------------------------------------------------

#### V. Description of the Device

The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.

#### VI. Summary of the Technical Characteristics

| UDS-94 | |
|-----------------------------------------------|-----------------------------------------------------------|
| Electrical Classification | Class I Equipment Type BF Applied Parts |
| Degree of Protection Against Ingress of Water | IPX0 Equipment |
| Mode of Operation | Continuous |
| Uroflow Rate | 0 to 50 ml/s |
| Uroflow Volume | 0 to 1100 ml |
| Pressure | -40 to 350 cm H2O |
| EMG† | -225 to 225 μV<br>Frequency: 2 to 800 Hz |
| Pump | 5 to 140 ml/min * |
| UPP Puller | 0.5 to 3 mm/s |
| Infusion | 0 to 1000 ml |
| T-Doc | -68 to 408 cmH2O |
| Data Conversion Rate | Min 10 Hz (min) up to 1000 Hz<br>(optional up to 5000 Hz) |
| Tetra Accessory | |
| Wavelengths | 785 nm, 808nm and 830nm |
| Energy Output | Up to 350 mJ |
| Type of Operation | Pulsed Only, 4 µsec |
| Class of Laser Products | Class I |

* Maximum pump rate is limited by size of catheter used

+ Sensitivity Range: +/- 1000 µV; High Pass: 800 Hz; Low Pass: 20 Hz

#### VII. Testing

Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory. Additional safety testing included electrical safety testing, laser safety testing and electromagnetic compatibility testing.

{2}------------------------------------------------

## VIII. Safety & Effectiveness

The Laborie Urodynamic with Tetra Accessory is substantially equivalent to the Laborie Urodynamic Analyzer K931574 .There are no substantial differences except for the additional technology of the Tetra component for non invasive diagnostic testing. Both devices have the same intended use and the new technology does not introduce any issues of safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# MAR - 5 2008

Ms. Barbara Mornet Regulatory Affairs Deputy and Official Correspondent Laborie Medical Technologies Corporation 400 Avenue D. Suite 10 WILLISTON VT 05495

Re: K073552

Trade/Device Name: Laborie Urodynamic System with Tetra Accessory Regulation Number: 21 CFR 876.1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Product Code: FEN and EXQ Dated: December 14, 2007 Received: December 20, 2007

Dear Ms. Mornet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a circular border with text that is difficult to read due to the image quality.

Protesting and Promoting Public Health

{4}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally. marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Traditional 510(k) Urodynamic Tetra Accessory Laborie Medical Technologies

5100(k) Number (IF KNOWN): Page 1 of 1

DEVICE NAME: Urodynamic System Tetra Accessory

### INDICATIONS FOR USE:

Laborie Urodynamic systems are intended for Urodynamic testing. The traditional equipment performs standard test including uroflometry, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra near infrared spectroscopy, uses non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms, that is patients who suffer from urinary incontinence

All Urodynamic equipment including the Laborie Urodynamic system with Tetra Accessory are for use under the direction of a licensed physician or health care professional in an office or hospital setting.

Prescription Use X

Heilut Lemer

ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number